Trulicity (dulaglutide) begins US marketing

Eli Lilly began US marketing of Trulicity (dulaglutide), a once-weekly GLP-1 receptor agonist given as a subcutaneous injection, under biologics license application BLA 125469 ^[1]. FDA records list the initial US approval year as 2014 ^[2]. The launch pens deliver a fixed dose in 0.5 mL of solution, and the drug is classed by FDA as a GLP-1 Receptor Agonist ^[1][2].

What the label says

Trulicity is indicated as an adjunct to diet and exercise to improve blood sugar control in adults and in pediatric patients 10 years of age and older with type 2 diabetes ^[2]. The current prescribing information also carries an indication to reduce the risk of major adverse cardiovascular events — cardiovascular death, non-fatal heart attack, or non-fatal stroke — in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors ^[2]. The sources do not say when that cardiovascular indication was added, so it is not clear it was part of the original launch label.

Dosing starts at 0.75 mg once weekly, and after four weeks may be increased to 1.5 mg once weekly for additional glycemic control ^[2]. The label describes further increases in 1.5 mg steps after at least four weeks at the current dose, up to a maximum of 4.5 mg once weekly ^[2]. For children 10 and older, the maximum recommended dose is 1.5 mg once weekly ^[2]. The higher strengths appear to have come later: FDA's product listing for the 3 mg pen shows a marketing start date of September 3, 2020 ^[1].

The injection can be taken at any time of day, with or without food, in the abdomen, thigh, or upper arm ^[2]. If a dose is missed, the label says it can be taken as soon as possible if there are at least three days (72 hours) until the next scheduled dose ^[2].

Safety information on the label

Trulicity carries a boxed warning: dulaglutide causes thyroid C-cell tumors in rats, and it is unknown whether the drug causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans ^[2]. It is contraindicated in people with a personal or family history of MTC or with Multiple Endocrine Neoplasia syndrome type 2, and in people who have had a serious hypersensitivity reaction to dulaglutide or its components ^[2].

Other warnings include acute pancreatitis, low blood sugar when combined with insulin or insulin secretagogues, serious hypersensitivity reactions such as anaphylaxis and angioedema, acute kidney injury from volume depletion, severe gastrointestinal reactions, diabetic retinopathy complications reported in a cardiovascular outcomes trial, and acute gallbladder disease ^[2]. The most common adverse reactions, at 5% or more, are nausea, diarrhea, vomiting, abdominal pain, and decreased appetite ^[2]. Because the drug slows stomach emptying, it can reduce the rate at which other oral medicines are absorbed ^[2].

Two label sections were updated more recently than the launch: severe gastrointestinal adverse reactions and pulmonary aspiration during general anesthesia or deep sedation, both dated 11/2024 ^[2].

Why it matters for patients

Trulicity's arrival gave people with type 2 diabetes another once-weekly injection rather than a daily one, with a pen device and a simple starting dose ^[2]. That convenience helped make weekly dosing the norm for this drug class in the years that followed.

Just as important is what the label does not cover: Trulicity is approved for blood sugar control and cardiovascular risk reduction in type 2 diabetes, not for chronic weight management ^[2]. Patients comparing GLP-1 options should note that indications, maximum doses, and age ranges differ from product to product, and that the boxed thyroid warning and the gastrointestinal side effect profile are shared features across much of the class ^[2].

FDA's product database currently lists 11 Trulicity entries from Eli Lilly, all subcutaneous injection solutions under BLA 125469 ^[1].